Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — Q3 2024 Earnings Presentation
58 slides from Nanoform Finland Oyj's earnings presentation, Nov 18, 2024
Slide 1: Nanoform Management Presentation Q3 2024 Interim Report
Nanoform Management Presentation Q3 2024 Interim Report November 18th, 2024
Slide 2: Disclaimer
Disclaimer Forward-Looking Statements This presentation contains forward-looking statements, including, without limitation, statements regarding Nanoform’s strategy, business plans and focus. The words may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” believe,” “est
Slide 3: Introduction: Key Business Highlights
Introduction Nanoform Breaker Slide & Option Key Business 2 Highlights CEO Edward Hæggström 3 Nanoform.com | @nanoform
Slide 4: Key strategy
Key strategy Nanoform work with In parallel, to show a All customers/partners to conservative industry active pharmaceutical enable both novel & the power of ingredients (API’s) existing molecules to nanoforming, we create should be Starmapped become new and up to a dozen improved medicines ‘product
Slide 5: Proprietary technology platforms
Proprietary technology platforms Small Large Formulation AI molecules molecules Highly differentiated STARMAP® 2.0 online Proven CESS®* Unique novel formulations and picks best candidates nanotechnology enables BIO nanoparticles unique drug delivery and accelerates new medicines through enable impro
Slide 6: Particle size is key
Particle size is key Smaller particle size can improve a drug’s bioavailability Pre-nanoforming Post-nanoforming • Smaller particles have a larger surface area • Larger surface area of particles enables improved bioavailability of a drug • The surface area increases 30-fold from a 10 micron1 sized p
Slide 7: Comparison of Nanoform's proprietary biologics technology vs existing technologies
Comparison of Nanoform’s proprietary biologics technology vs existing technologies Nanoformed Spray dried Lyophilized / freeze dried Perfect spheres, highly flowable and aerodynamic, Sticky, poor flowability, raisin shaped Flaky morphology, dry cake, no flowability great packing and injection proper
Slide 8: Simplified value chain
Simplified value chain High level overview of Nanoform’s value chain and business model Bulk API* Launch of new drugs, improving existing drugs & reducing clinical attrition Clients Nanoformed Revenue • Global large pharma API* • Fixed fee per project • Mid-sized and specialty pharma • Royalty as a
Slide 9: Nanoform business highlights Q3 2024
Nanoform business highlights Q3 2024 1 New quarterly record on customer non-GMP projects signed. 2 Revenue growth is back and is expected to accelerate in coming quarters and years. Following completion of in vitro proof of concept studies of a novel plasma-derived therapy formulation with 3 Takeda,
Slide 10: Financials
Nanoform Breaker Slide Financials Option 2 CFO Albert Hæggström 10 Nanoform.com | @nanoform
Slide 11: Number of projects signed – new record in a quarter
Number of projects signed – new record in a quarter 11 Nanoform.com | @nanoform
Slide 12: Revenue +21% y/y in 3Q, and +19% q/q despite summer period
Revenue +21% y/y in 3Q, and +19% q/q despite summer period* *3Q has historically had lower revenue recognized than 2Q as the hours worked are lower due to summer holiday period 12 Nanoform.com | @nanoform
Slide 13: Gross profit and gross margin rose after Fimea license
Gross profit and gross margin rose, trend should continue after receiving Fimea license for our new GMP QC lab Excluding the cost of external GMP QC services, related to the nanoenzalutamide project, our underlying gross margin has remained above 90%. After receiving the license from Fimea for our G
Slide 14: >90% of GMP QC work insourced after getting Fimea license in August
>90% of GMP QC work insourced after getting Fimea license in August GMP Quality Control outsourced up to September 2024 GMP Quality Control as of October 2024 and going forward Nanoformed AP1: IPC analysis Release analysis Stability study analysis Stabalibity study management Cleaning validation: Cl
Slide 15: Improvement in operating free cash flow to continue
Improvement in operating free cash flow to continue At the end of 3Q24, Nanoform had some than EUR 46m in cash & short-term government bonds and no debt 15 Nanoform.com | @nanoform
Slide 16: Nanoform near-term business targets 2024
Nanoform near-term business targets 2024 Topic Target Status Bulk 16+1 in 9M2024 Increased number of non-GMP API and GMP Customer Projects vs projects signed in 2024 vs 2023 * 17+1 in 9M2023 Improved operating EUR -16.7m 9M2024 Operating vs free cashflow Free Cashflow EUR -17.2m in 9M2023 in 2024 vs
Slide 17: Product Kernels
Nanoform Product Breaker Kernels Slide Option Chief Development 2 Officer Peter Hänninen 17 Nanoform.com | @nanoform
Slide 18: Product Kernels
Product Kernels Nanoform work with In parallel, to show a All customers/partners to conservative industry active pharmaceutical enable both novel & the power of ingredients (API’s) existing molecules to nanoforming, we create should be Starmapped become new and up to a dozen improved medicines ‘prod
Slide 19: Product Kernels
Product Kernels* Nanoform 'product kernel' project data Preclinical (Nanoform) Clinical (Nanoform) Commercial (Nanoform) Pre- Dosage form PoP* / Dosage Commercial Expected Delivery route Phase 1 / Targeted market Project Originator API Indication PoC formulation + development form Pivotal partnering
Slide 20: Commercial
Nanoform Breaker Slide Commercial Option 2 CCO Christian Jones 20 Nanoform.com | @nanoform
Slide 21: Originator/Innovator customer business
Originator/Innovator customer business Nanoform work with In parallel, to show a All customers/partners to conservative industry active pharmaceutical enable both novel & the power of ingredients (API’s) existing molecules to nanoforming, we create should be Starmapped become new and up to a dozen i
Slide 22: Commercial Activities
Commercial Activities Dr Ajit Shetty, former Chairman of Director Sophie Janbon and Director Nanoform visit Bluepharma in Tomoyasu Nakamura and Shigerau Janssen, and Dr Makarand Jawadekar, Geof Wolfenden, AstraZeneca Plc, visit Portugal, ONConcept® consortium Yokohama, CBC, present Nanoform former P
Slide 23: Cumulative number of customers and projects signed
Cumulative number of customers and projects signed Customers Customer Projects 88 49 42 71 33 48 21 30 8 12 3 2 2019 2020 2021 2022 2023 9M 2019 2020 2021 2022 2023 9M 2024 2024 23 Nanoform.com | @nanoform
Slide 24: Nanoform customer projects – therapy area overview
Nanoform customer projects – therapy area overview* Pre-Clinical Phase I Phase II & III Marketed/505b2 Cardiology Immunology/Inflammation Metabolism and Endocrinology Infectious Disease (e.g. Anemia) (e.g. Cystic Fibrosis) (e.g. Adrenal Hyperplasia) (e.g. HIV) Gastroenterology Dermatology/Oncology N
Slide 25: Small Molecules customer projects and formulation challenges
Customer projects and customer’s formulation challenge Customer Pre- Company Type Therapeutic Area Phase 1 Phase 2 Phase 3 Marketed Formulation Challenge Clinical Mid-Size Pharma/Biotech Oncology Drug Load Mid-Size Pharma/Biotech Autoimmune Food Effect/Dose Reduction Large Pharma Immunology Dissolut
Slide 26: Upcoming events
Upcoming events November 20 SEB Healthcare Seminar 2024, Stockholm November 26 DNB 15th Annual Nordic Healthcare Conference, Oslo November 26-27 BOS, Manchester November 28 Stora Aktiedagarna - Aktiespararna, Stockholm December 11-13 DDL 2024, Edinburgh December 16 Nordea Growth Day, Helsinki Januar
Slide 27: Q&A
Q&A Nanoform Breaker Slide Q & A2 Option www.nanoform.com Nanoform headquarters in Helsinki, Finland San Diego - New York - Lisbon - Oxford – London - Cambridge - Bordeaux - Stockholm – Budapest - Helsinki www.nanoform.com San Diego - Chicago - New York - Lisbon - Manchester - Oxford - London - Camb
Slide 28: Appendix
APPENDIX 28 Nanoform.com | @nanoform
Slide 29: Substantial progress in Nanoforming solutions with in-vitro, in-vivo, and clinical results
Nanoform has made substantial progress in Nanoforming solutions with in-vitro, in-vivo, and clinical study results Oncology: Replaced amorphous solid dispersion (ASD) formulations with nanocrystalline high drug load formulations, matching bioequivalence for Enzalutamide and Apalutamide where life cy
Slide 30: Nanoform commercial highlights Jan-Sep 2024
Nanoform commercial highlights Jan-Sep 2024 NOV New quarterly record in customer project intake SEP Nanoform and Celanese expand collaboration into long-acting biologics delivery through small implants AUG Nanoform initiates collaboration with Takeda on their plasma-derived therapy development (biol
Slide 31: Business case Amorphous Solid Dispersions (ASDs)
Business case Amorphous Solid Dispersions (ASDs) Amorphous solid dispersion (ASD) medicines are currently the leading formulation strategy for poorly soluble APIs and there are ~50 marketed medicines globally that are ASDs and sell for ~$50bln annually Nanoformed and nanocrystalline medicines (e.g.
Slide 32: Project Nanoenzalutamide (oral tablet for prostate cancer)
Project Nanoenzalutamide (oral tablet for prostate cancer) Clinical results 26.1.2024: Very promising relative bioavailability study of nanocrystalline-enabled enzalutamide* (nanoenzalutamide) tablet formulation. Nanoforming benefits: 1) Opportunity for an improved and differentiated finished produc
Slide 33: Takeda (plasma-derived formulations for rare conditions)
Takeda (plasma-derived formulations for rare conditions) MAY 7, 2024 - NANOFORMED HIGH-CONCENTARION BIOLOGICS FORMULATION FOR SUBCUTANEOUS DELIVERY RESULTS TO BE PRESENTED BY TAKEDA AD DDF SUMMIT The proof-of-concept study data support the potential of Nanoform’s patented biologics platform to achie
Slide 34: Project Nanoapalutamide (oral tablet for prostate cancer)
Project Nanoapalutamide (oral tablet for prostate cancer) FEBRUARY 19, 2024 – APALUTAMIDE STUDY AGAIN DEMONSTRATES THE ADVANTAGES OF NANOFORMING OVER TRADITIONAL CANCER TREATMENT FORMULATIONS Positive results from own pre-clinical, in-vivo study of a nanocrystalline-enabled apalutamide oral formulat
Slide 35: Project Glioblastoma (hydrogel for central nervous system cancer)
Project Glioblastoma (hydrogel for central nervous system cancer) Nanoform customer TargTex S.A. was granted Orphan Drug Designation by FDA for its nanoformed drug candidate TTX101 to be used in patients with malignant gliomas (October 2023). The orphan drug designation follows the generation of a p
Slide 36: Visit to Nanoform HQ in Helsinki, September 16th, 2024
Dr Ajit Shetty, former Chairman of Janssen, the Janssen Pharmaceutical Companies of Johnson & Johnson, and Dr Makarand Jawadekar, former Pfizer global R&D executive, visting Nanoform HQ in Helsinki - September 16th, 2024 Page 15 36 Nanoform.com | @nanoform
Slide 37: Takeda showcases Nanoform technology for high concentration biologics
Takeda showcases Nanoform technology for high concentration biologics – DDF Summit Berlin 2024 37 Nanoform.com | @nanoform
Slide 38: Celanese showcases Nanoform technology for long acting small molecule drug release
Celanese showcases Nanoform technology for long acting small molecule drug release – DDF Summit Berlin 2024 38 Nanoform.com | @nanoform
Slide 39: Nanoform growth since IPO 2020 in brief
Nanoform growth since IPO 2020 in brief IPO June 2020 September 2024 Growth Employees 50 177 ~3x Manufacturing lines 5 20 ~4x Customers enrolled 5 49 ~9x Customer projects started 5 88 ~18x Patents granted 5 42 ~8x 39 Nanoform.com | @nanoform
Slide 40: Commercial Relationships 2019 – Q3 2024
Commercial Relationships 2019 – Q3 2024 Customer mix Selection of partners 11 major Takeda pharma 36 mid-sized, specialty pharma 2 co- & biotech developments companies 3 collaborations 40 Nanoform.com | @nanoform
Slide 41: Propensity to crystallise in CESS
STARMAP® predicts that nanoforming is an attractive alternative to ASDs (Amorphous Solid Dispersions) Amorphous solid dispersions (n=46 APIs) ✓ STARMAP predicts that 78% of marketed ASD APIs fall 5 within our processing “sweet spot" Propensity to crystallise in CESS ✓ 46 ASDs have been Starmapped 4
Slide 42: Within marketed ASDs 31/39 passed our STARMAP screen
Within marketed ASDs 31/39 passed our STARMAP® screen and are predicted to be amenable to nanoforming* Belsomra® suvorexant Pifeltro® doravirine Braftovi® encorafenib Prezista® darunavir Cesamet® nabilone Prograf® tacrolimus Deltyba® delamanid Qinlock® ripretinib Erleada® apalutamide Sotyktu® deucra
Slide 43: The structural pharma R&D problem in the pharma industry
The structural pharma R&D problem in the pharma industry Fewer than 50 drugs approved in the US annually on average… …while the global pharma industry R&D expenditure exceeds $200B Annual number of novel drug approvals by FDA 2010-2023 Global pharmaceutical R&D spending 2014-2028E (USDbn) Chemical B
Slide 44: Low bioavailability is the key issue
Low bioavailability is the key issue Poor bioavailability and low efficacy most common reasons for drug failure Majority of new drugs suffer from poor solubility Solubility Reasons for drug failure in pre-clinical trials (share of molecules) High Low 45% 40% 35% Class I1 Class II1 On market: 35% On
Slide 45: Small molecules - Small is powerful
Small molecules - Small is powerful® 45 Nanoform.com | @nanoform
Slide 46: Nanoform is here to fill the gap
Nanoform is here to fill the gap Giving Enabling Improving unsuccessful new drugs existing drug candidates a drugs second chance > 20,000 drugs in > 5,800 > 58,000 failed development* existing drugs* drugs in the last 40 years* 46 *Source: Nanoform and Pharmaprojects® | Informa, 2022 Nanoform.com |
Slide 47: Small Molecules - Proprietary technology
Small Molecules - Proprietary technology Green technology Controlled Expansion of Supercritical Solutions - CESS® Contro lled ➢ Relatively simple process developed through combining deep knowledge in physics, chemistry, and pharma 47 The CESS® technology platform was described in detail in the IPO p
Slide 48: CESS Superior to Existing Technologies
CESS® Superior to Existing Technologies Controlled Expansion of Solid dispersion Supercritical Solutions Jet milling Nanomilling (e.g. spray drying) (CESS®) Extracts API from API is dispersed into a solid Application of energy to supercritical CO2 by applying material, which dissolves API particle s
Slide 49: Large molecules - Proprietary technology
Large molecules - Proprietary technology Green technology Nanoforming process for biologics API = active pharmaceutical ingredient 49 Nebulization = turns liquid into mist Nanoform.com | @nanoform Ionization = particles electrically charged
Slide 50: Comparison of Nanoform's proprietary biologics technology vs existing technologies
Comparison of Nanoform’s proprietary biologics technology vs existing technologies Nanoformed Spray dried Lyophilized / freeze dried Perfect spheres, highly flowable and aerodynamic, Sticky, poor flowability, raisin shaped Flaky morphology, dry cake, no flowability great packing and injection proper
Slide 51: Revenue drivers & industry attrition rates
Revenue drivers & industry attrition rates Nanoform pre-clinical and clinical revenue drivers Global Pharmaceutical industry’s pre-clinical and clinical success rates Non-GMP GMP ➢ Attrition between previous and current phase ➢ Price per phase per API ➢ # of active customers Phase I, ➢ Time lag betw
Slide 52: Nanoform – Attractive revenue model
Nanoform – Attractive revenue model Predictable revenue streams through capitalizing the entire pharmaceuticals value chain Phase Proof of Concept / Proof of Process Phase I – III trials Drugs on the market Certification Non-GMP GMP GMP • Proof of concept study - assessment of the • API for clinical
Slide 53: Nanoform mid-term business targets 2025
Nanoform mid-term business targets 2025 >70 35 lines of which 200-250 new APIs per 7-14 are employees year GMP compliant >90% Cash flow gross margin positive 53 Nanoform.com | @nanoform
Slide 54: Experienced global sales team driving commercialization
Experienced global sales team driving commercialization – Locations and previous experiences Manchester Oxford London Cambridge Helsinki Chicago Budapest Bordeaux New York Japan (CBC) San Diego Lisbon 54 Nanoform.com | @nanoform
Slide 55: Management team: Multi-disciplinary with international merits
Management team: Multi-disciplinary with international merits CEO & Co-founder; Ph.D. (Applied physics), MBA CFO and member of the Board; B.Sc. (Economics) Edward Hæggström • Professor at the University of Helsinki, Head of Electronics Research Lab. Albert Hæggström • 20 years of finance and investi
Slide 56: Board of directors: Top executives from leading industry positions
Board of directors: Top executives from leading industry positions Miguel Calado Albert Hæggström Chairman of the Board CFO and Board Member • Previously CFO at international particle engineering CDMO • 20 years of finance and investing experience company Hovione Group • Prior roles include position
Slide 57: Selection of Nanoform Institutional Shareholders
Selection of Nanoform Institutional Shareholders 57 Latest ownership data can be found at: www.nanoform.com/en/ownership-structure/ Nanoform.com | @nanoform
Slide 58: Thank you
Thank you FURTHER ENQUIRIES CEO Edward Hæggström - edward.haeggstrom@nanoform.com, +358 29 370 0150 CFO Albert Hæggström - albert.haeggstrom@nanoform.com, +358 29 370 0150 DIR Henri von Haartman - hvh@nanoform.com, +46 76866 50 11 Nanoform.com | @nanoform